History

The firm was founded, as Hyman & Phelps, on St. Patrick’s Day in 1980. There were three founders: Paul Hyman, Jim Phelps, and Bob Dormer. They left a New York-based firm to create their own practice. The goal of the new firm was to provide service to clients regulated primarily by the Food and Drug Administration, the agency with which the three founders had extensive experience. When Steve McNamara joined the practice in 1984, the firm became known as Hyman, Phelps & McNamara. Later that year, the firm incorporated, and has since been known as Hyman, Phelps & McNamara, P.C.

The founders intended to maintain the firm at a size to meet the needs of food and drug clients. Over the years, the size of the firm has grown considerably due to the ever-increasing needs of those clients. As government regulation of the food, dietary supplement, drug, biologic, medical device and cosmetic industries has escalated, our food and drug practice has expanded into many related subspecialties, including controlled substances, fraud and abuse, reimbursement and payor issues, and advertising and claims substantiation, to name a few.

The backgrounds and experiences of our attorneys support the breadth of the firm’s practice. Our attorneys have had experience in many branches of the federal government, including the Food and Drug Administration, the Department of Justice (Office of Consumer Litigation), U.S. Attorneys Offices, and the Drug Enforcement Administration. Our attorneys have been general counsels in major pharmaceutical houses, and have served in industry trade associations. Several have scientific backgrounds in areas that complement our practice, such as clinical research and the practice of pharmacy. One member is a former judge, and several were law clerks. Together the firm’s attorneys bring a seasoned focus to the issues that confront food, dietary supplement, drug, biologic, medical device, and cosmetic companies.

Further, in addressing clients’ issues, we have a vast network of resources at our disposal to supplement our combined expertise. Because aspects of our regulatory practice often involve complex or novel scientific issues, we work collaboratively with physicians and consultants, as needed, who are able to provide targeted medical or scientific expertise to help accomplish the regulatory goals of our clients. In addition, we have longstanding relationships with regulatory counsel in foreign jurisdictions – including the European Union, Asia, Canada, Mexico, South America, and Australia – in which clients may seek to market their products, source ingredients or materials, hold clinical trials, or may otherwise require assistance.

Our goal is to provide prompt and economical professional services suited to each client’s specific needs. The firm’s clients are as diverse as the regulatory issues they face. They range from individuals and start-up companies with no in-house legal staff to large multinational corporations. In addition, other law firms retain HPM to provide targeted expertise in food and drug law to assist their clients. HPM works to avoid legal problems when possible, and to help solve them when necessary. The firm helps companies conduct business as efficiently and profitably as possible by providing advice and counsel on meeting current and future regulatory requirements.